TABLE 2.
Adverse events reported by two or more subjects in the repeat-dose study
| AE | No. (%) of AEs with the following treatmenta: |
|||||
|---|---|---|---|---|---|---|
| 10 mg (n = 8) | 25 mg (n = 10) | 50 mg (n = 9) | MDZ (n = 12) | 25 mg + MDZ (n = 10) | Placebo (n = 5) | |
| Any AE | 4 (50) | 1 (10) | 7 (78) | 1 (8) | 1 (10) | 1 (20) |
| Any AE related to the investigational product | 2 (25) | 1 (10) | 6 (67) | 1 (8) | 0 | 1 (20) |
| Most common AEs | ||||||
| Headache | 1 (13) | 0 | 2 (22) | 0 | 0 | 0 |
| Pharyngolaryngeal pain | 1 (13) | 0 | 1 (11) | 0 | 0 | 1 (20) |
| ECG application site pruritis | 0 | 0 | 1 (11) | 0 | 1 (10) | 0 |
| Pruritis | 0 | 0 | 2 (22) | 0 | 0 | 0 |
| Most common drug-related AEs | ||||||
| Headache | 0 | 0 | 2 (22) | 0 | 0 | 0 |
| Pharyngolaryngeal pain | 0 | 0 | 1 (11) | 0 | 0 | 1 (20) |
| Pruritis | 0 | 0 | 2 (22) | 0 | 0 | 0 |
a
10 mg, 10 mg of S/GSK1349572 suspension once daily for 10 days; 25 mg, 25 mg of S/GSK1349572 suspension once daily for 9 days; 50 mg, 50 mg of S/GSK1349572 suspension once daily for 10 days; MDZ, 3-mg single dose of MDZ; 25 mg + MDZ, 25 mg of S/GSK1349572 suspension plus 3 mg MDZ once daily for 1 day. n, number of subjects.